FDA approves powerful new pain pill despite fears of abuse

It's a capsule of pure hydrocodone so powerful that one accidental dose can kill. And a growing chorus of doctors, lawmakers, drug-control officials and others fear this new pain-relief drug -- Zohydro ER -- could ignite another deadly wave of prescription drug abuse just as Kentucky is trying to curb its pill addiction.

"We could see the OxyContin days come back, just in a new form," said Dan Smoot, president and chief executive officer of the Eastern Kentucky anti-drug organization Operation UNITE, referring to the drug that first sparked Appalachia's prescription abuse problem in the late 1990s.

Smoot is among a slew of local and national drug control and law enforcement officials, health and addiction professionals and U.S. lawmakers raising concerns about extended release Zohydro, which was approved by the U.S. Food and Drug Administration in the fall -- against the advice of its own advisory board.

It's set to hit the market early this month, and last week a coalition of more than 40 health, consumer and other organizations urged the FDA to revoke its approval.

According to experts cited by 28 attorneys general, including Kentucky's Jack Conway, extended-release Zohydro is five to 10 times more potent than traditional hydrocodone products such as Vicodin, which are mixed with milder painkillers.

And, unlike recent formulations of OxyContin and Opana, Zohydro is not crush-resistant, meaning it's easier for addicts to abuse by crushing and then snorting or injecting.

More than 1,000 Kentuckians die annually of drug overdoses, mainly from prescription drugs, but those numbers have been leveling off in recent years as the state has cracked down on the problem through a 2012 law that targets pill-pushing clinics and doctors and tightly regulates and monitors prescription painkillers.

Several Kentucky lawmakers and officials said Zohydro's approval threatens the state's progress against prescription drug abuse.

"It's baffling. And it's a step backwards," added U.S. Rep. Hal Rogers, R-Kentucky 5th District, adding that not requiring an abuse-deterrent formulation "sends the wrong message to companies that want to develop new drugs."

Republican U.S. Sen. Mitch McConnell and two other senators sent a letter to the FDA earlier this month protesting the Zohydro decision, saying the drug "poses a significant danger to our constituents, as it could worsen the drug abuse epidemic in our country."

But FDA officials say they reviewed Zohydro's safety and effectiveness, and it met their requirements.

They said the benefits outweigh the risks for patients in severe pain who require round-the-clock opioid treatment, can't be helped by other drugs and use this drug correctly.

Officials at the California drug-maker Zogenix said the company is committed to going "above and beyond FDA requirements" to promote appropriate use of Zohydro and will monitor for misuse and allow an outside group of experts to analyze the monitoring data and make recommendations.

They also said they are working on an abuse-resistant formulation.

But such assurances don't allay the concerns of critics, such as Van Ingram, executive director of the Kentucky Office of Drug Control Policy.

"We're very concerned about extended-release products that don't have abuse deterrents," he said. "Our state was hit hard when OxyContin came in without it."

Recovering addict Kelly Burton of Louisville, said hydrocodone was the first prescription drug she abused. She said she liked the way it made her feel, and "it opened doors for me" that led to OxyContin, Dilaudid and finally heroin.

She had withered to 85 pounds when she finally sought help at The Healing Place in 2012.

"I think (Zohydro) is going to be another highly-abused prescription medication," said Burton, who has been sober since November 2012 and now works at a medical clinic at the Healing Place. "Any door that's open, an addict will take."

State figures show hydrocodone was the top prescribed controlled substance in Kentucky in 2012, comprising 41.5 percent of all doses.

It was also the third most frequently detected substance in the blood of Kentuckians who died of drug overdoses, found in 26 percent of victims.

Zohydro is stronger than other hydrocodone products because it's pure and is designed to be released slowly over 12 hours.

The drug maker's educational information on the pills warns patients of potential dangers, saying the drug "exposes users to risks of addiction, abuse and misuse, which can lead to overdose and death." It urges doctors to instruct patients to swallow pills whole "to avoid exposure to a potentially fatal dose of hydrocodone."

It also says accidental consumption of the pills, especially in children, can be deadly.

The FDA's scientific advisory panel cited concerns about misuse and abuse when it voted 11-2 against approving Zohydro.

FDA officials said though they didn't take that recommendation, they are committed to ongoing efforts to reduce misuse of all opioids, while ensuring patients in pain still have access to the drugs.

"Opioids are important pain-relieving medications that can provide significant benefits for patients when use properly for their approved indications," they wrote in answer to questions from The Courier-Journal.

FDA officials also pointed out that Zohydro will be regulated as a Schedule II controlled substance, meaning it can only be dispensed through a physician's written prescription, with no refills allowed.

Other hydrocodone products are classified in the less-restricted Schedule III -- although the FDA has recommended moving them to Schedule II, and Kentucky's new drug law already treats hydrocodone as a Schedule II drug.

Zogenix said it's also taking a number of steps to prevent abuse of its product: compensating drug representatives based on educational goals and not volume of product sold during the first year; providing educational resources for patients and doctors; and supporting the Schedule II classification.

The company says Zohydro provides "a new treatment option" for chronic pain patients who have developed tolerance to other opioids, are not getting enough pain relief, or are experiencing side effects from other narcotic pills.

Officials said many other hydrocodone painkillers contain acetaminophen -- the active ingredient in Tylenol -- which can be dangerous for patients who use these pills for a long time. They noted that more than half of liver transplants are caused by acetaminophen overdoses from overusing these sorts of combination drugs.

Demetra Antimisiaris, a pharmacist with UofL Physicians and an assistant professor at UofL, agreed that too much acetaminophen can seriously damage the liver.

"It's pretty insidious," she said. "And once it happens, it's a terrible death." She said there are acetaminophen-free narcotic painkillers on the market, such as oxycodone and morphine, but there still may be a need for more.

"I think clinically, for elderly people, (Zohydro) will be another option when we can't use something else," she said. "And I don't think this will be a drug abused any more than the others."

Dr. James Patrick Murphy, a pain and addiction specialist and president of the Greater Louisville Medical Society, agreed there are some pain patients who could benefit from Zohydro, but said it's a small group.

"The big worry is that this is another pure narcotic that could be easily crushed into an injectible form that could make it very dangerous," he said.

David Vanlandingham, a UofL pharmacy faculty member who also works part-time in a retail pharmacy, said he sees no need for Zohydro -- "I don't see any benefit over oxycodone at this point."

Dr. Christopher Michael Stewart, associate professor of psychiatry at UofL and medical director for Jefferson Alcohol and Drug Abuse Center, said he understands Zohydro may fill a small niche, but he generally doesn't support using narcotics for long-term pain not caused by cancer.

The potential for abuse is not worth the risk, he said, especially since many doctors who prescribe such medications are not trained in pain management.

"This drug coming out, it undermines your faith in the FDA," he said. "This drug is going to be abused."

Attorneys general from around the nation have asked the FDA to reconsider its approval of Zohydro, or "set a vigorous timeline" for it to be made abuse-resistant and work with other federal agencies to restrict marketing and prescription of the drug.

"We do not want to see the great strides we have made in Kentucky combating prescription drug abuse reversed," Conway said in a statement after signing a December letter with his colleagues. "For decades, we have fought the disastrous effects of the illegal marketing of the drug OxyContin.

The FDA's decision to approve the drug doesn't make sense."

Carl Varney, a 34-year-old recovering prescription drug addict from Manchester, Ky., said even though Kentucky's overdose deaths have leveled off, addiction continues to plague the state, and addicts are vulnerable to any new and powerful narcotic.

"This prescription drug problem has roots here. Even if you chop off one plant, it tends to come up in another way," said Varney, now a coalition coordinator for Operation UNITE. "You have to educate people about what's coming up, and educate parents on a new temptation out there."

Lawmakers and state officials said they hope their opposition to Zohydro spurs the FDA to change its stance on the drug.

"I have heard from many Kentuckians, including family members who have lost loved ones to a prescription drug overdose, and members of the law enforcement and medical communities regarding their concerns with extended-release, pure hydrocodone products coming to the market," McConnell said in a statement. "

I look forward to learning from FDA how they plan to safeguard the use of these powerful drugs to prevent their abuse." Rogers co-signed a bipartisan letter opposing the Zohydro decision in November -- and said he and his House colleagues have yet to hear back from the FDA. "We'll keep pressuring them," he said. "We have grave concerns."